• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name radiological computer assisted detection/diagnosis software for lesions suspicious for cancer
510(k) Number K181704
Device Name Transpara
Applicant
ScreenPoint Medical BV
Stationsplein 26
nijmegen,  NL 6512ab
Applicant Contact nico karssemeijer
Correspondent
ScreenPoint Medical BV
Stationsplein 26
nijmegen,  NL 6512ab
Correspondent Contact nico karssemeijer
Regulation Number892.2090
Classification Product Code
QDQ  
Date Received06/27/2018
Decision Date 11/21/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-